Atrial FibrillationPhase 4NCT04209959
Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation
A Phase 4 study testing nifekalant in people with Atrial Fibrillation, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- nifekalant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented symptomatic persistent or longstanding persistent AF
- An absence of response to, unacceptable side effects from, or unwillingness to take antiarrhythmic agents
- Willingness to receive combined ablation strategy, including bilateral circumferential pulmonary vein isolation and linear ablation
- Failure to terminate AF to after combined ablation strategy
- Willingness to receive intravenous treatment with nifekalant during the procedure
Who cannot join
- A history of nontraumatic intracerebral hemorrhage at any time
- Gastrointestinal bleeding within the past six months
- Major surgery within thirty days
- A known bleeding diathesis or coagulation disorder
- A confirmed thrombus in the left atrium by esophageal ultrasound
- Renal failure requiring dialysis
Show all 11Show fewer
- Pregnant or lactating
- A left ventricular ejection fraction (LVEF) of 30% or less
- Ventricular tachycardia with prolonged QT interval
- Patients with QTc interval of more than 500 ms
- Torsades de pointes (Tdp), or Brugada syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
Official title: Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation：a Single-center Randomized Controlled Trial
Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. Radiofrequency catheter ablation (RFCA) are the effective treatment for patients with drug-refractory symptomatic paroxysmal or persistent AF. However, the successful rate of RFCA for persistent AF during the first procedure still relatively low, the investigators also need pharmacological cardioversion or external electrical conversion. Several studies showed intravenous nifekalant injection after RFCA provided relative high rate of sinus conversion during catheter ablation in paroxysmal or persistent AF. Nevertheless, there is still no acceptable universal opinion on which dosage of nifekalant is preferable for converting AF during the operation. In order to address this issue, the investigators initiated the study to evaluate the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation.
Read the detailed description
Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. Its prevalence increases with advanced age. About one percent of patients suffering from AF are younger than sixty years, twelve percent are between seventy-five and eighty-five years, and about thirty-three percent are older than eighty years. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. At present, the medical anti-arrhythmic therapy and radiofrequency ablation have been as important treatment for patients with AF. Compared with the treatment of anti-arrhythmia therapy, radiofrequency ablation could significantly improve the rate of long-term AF-free survival. Thus, radiofrequency ablation has become the radical method for patients suffering AF.
However, the successful rate of first radiofrequency ablation for patients with persistent AF was only about 65%. Due to low sinus maintenance rate after catheter ablation, anti-arrhythmic drugs (AADs) or external electric cardioversion was used to converting atrial fibrillation during the procedure. Compared with traditional AADs for pharmacologic cardioversion, such as quinidine, propafenone and amiodarone, nifekalant is a new class III AADs for rapid cardioversion of persistent AF during radiofrequency ablation, and its prevalence of AF termination during procedure was approximately 64.6%. Nevertheless, the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation has not been tested in large, randomized, controlled trials, and guidelines provide no clear consensus regarding the best dose recommended.
In order to address this issue, the investigators initiated the study to evaluate the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- nifekalant
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nifekalantDrug
Nifekalant was randomly given intravenously as a loading dose of 0.3 mg/kg, 0.4 mg/kg, or 0.5 mg/kg for five minutes without the continuous infusion for all study population, while blood pressure, surface electrocardiograms (ECG), intracardiac electrograms were monitored for half an hour. While nifekalant was given intravenously, QT interval, QTc interval and RR interval were recorded at 0, 1, 3, 5, 10, 15, 20 and 30minutes, respectively, because drug action almost disappeared within 30minutes since a single dose of intravenous nifekalant injection. These doses of nifekalant were determined based on the results of the previous study and the medicine operation instruction. Once AF continued after administration or Torsade de points was observed, external electrical cardioversion was given immediately.
| Study group | Role | What they receive |
|---|---|---|
| low dose group | Experimental | Not described Receives: Drug: nifekalant |
| middle dose group | Experimental | Not described Receives: Drug: nifekalant |
| high dose group | Experimental | Not described Receives: Drug: nifekalant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the successful rates of different doses of nifekalant instant cardioversion of persistent atrial fibrillation after radiofrequency ablation
Participants are randomized to one of three groups: low dose group (0.3mg/kg), middle dose group (0.4mg/kg), or high dose group (0.5mg/kg). The successful rates of different doses of nifekalant instant cardioversion were reported in terms of count and percentage, respectively.
Measured: up to 12 months
The occurrence of adverse events, including sinus bradycardia, cardiac arrest, Torsade de points and ventricular fibrillation confirmed in standard 12-lead ECGs and intracardiac electrograms within 30 minutes among different treatment groups.
The occurrence of adverse events, such as sinus bradycardia, cardiac arrest, Torsade de points and ventricular fibrillation confirmed in standard 12-lead ECGs were represented in terms of count and percentage, respectively.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209959
- Sponsor's protocol ID
- 2014[023]
- Status last verified
- Jan 2019
- First submitted
- 3 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Different Doses of Nifekalant Instant Cardioversion of Persistent Atrial Fibrillation During Radiofrequency Ablation：a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04209959
- Acronym / sponsor ID
- 2014[023]
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. Radiofrequency catheter ablation (RFCA) are the effective treatment for patients with drug-refractory symptomatic paroxysmal or persistent AF. However, the successful rate of RFCA for persistent AF during the first procedure still relatively low, the investigators also need pharmacological cardioversion or external electrical conversion. Several studies showed intravenous nifekalant injection after RFCA provided relative high rate of sinus conversion during catheter ablation in paroxysmal or persistent AF. Nevertheless, there is still no acceptable universal opinion on which dosage of nifekalant is preferable for converting AF during the operation. In order to address this issue, the investigators initiated the study to evaluate the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation.
Detailed description
Atrial fibrillation (AF) is one of the most common tachyarrhythmias with substantial morbidity, disability and mortality. Its prevalence increases with advanced age. About one percent of patients suffering from AF are younger than sixty years, twelve percent are between seventy-five and eighty-five years, and about thirty-three percent are older than eighty years. It is estimated that the number of patients with AF is expected to reach 7 million by 2050. At present, the medical anti-arrhythmic therapy and radiofrequency ablation have been as important treatment for patients with AF. Compared with the treatment of anti-arrhythmia therapy, radiofrequency ablation could significantly improve the rate of long-term AF-free survival. Thus, radiofrequency ablation has become the radical method for patients suffering AF.
However, the successful rate of first radiofrequency ablation for patients with persistent AF was only about 65%. Due to low sinus maintenance rate after catheter ablation, anti-arrhythmic drugs (AADs) or external electric cardioversion was used to converting atrial fibrillation during the procedure. Compared with traditional AADs for pharmacologic cardioversion, such as quinidine, propafenone and amiodarone, nifekalant is a new class III AADs for rapid cardioversion of persistent AF during radiofrequency ablation, and its prevalence of AF termination during procedure was approximately 64.6%. Nevertheless, the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation has not been tested in large, randomized, controlled trials, and guidelines provide no clear consensus regarding the best dose recommended.
In order to address this issue, the investigators initiated the study to evaluate the efficacy and safety of different doses of intravenous nifekalant injection in the rapid cardioversion of persistent AF during radiofrequency catheter ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose group | Experimental | Drug: nifekalant |
| middle dose group | Experimental | Drug: nifekalant |
| high dose group | Experimental | Drug: nifekalant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented symptomatic persistent or longstanding persistent AF
- An absence of response to, unacceptable side effects from, or unwillingness to take antiarrhythmic agents
- Willingness to receive combined ablation strategy, including bilateral circumferential pulmonary vein isolation and linear ablation
- Failure to terminate AF to after combined ablation strategy
- Willingness to receive intravenous treatment with nifekalant during the procedure
Key exclusion criteria (11 listed)
- A history of nontraumatic intracerebral hemorrhage at any time
- Gastrointestinal bleeding within the past six months
- Major surgery within thirty days
- A known bleeding diathesis or coagulation disorder
- A confirmed thrombus in the left atrium by esophageal ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nifekalantNifekalant was randomly given intravenously as a loading dose of 0.3 mg/kg, 0.4 mg/kg, or 0.5 mg/kg for five minutes without the continuous infusion for all study population, while blood pressure, surface electrocardiograms (ECG), intracardiac electrograms were monitored for half an hour. While nifekalant was given intravenously, QT interval, QTc interval and RR interval were recorded at 0, 1, 3, 5, 10, 15, 20 and 30minutes, respectively, because drug action almost disappeared within 30minutes since a single dose of intravenous nifekalant injection. These doses of nifekalant were determined based on the results of the previous study and the medicine operation instruction. Once AF continued after administration or Torsade de points was observed, external electrical cardioversion was given immediately. | Drug | high dose group, low dose group, middle dose group |
Primary outcome
Comparison of the successful rates of different doses of nifekalant instant cardioversion of persistent atrial fibrillation after radiofrequency ablation
Time frame: up to 12 months
Participants are randomized to one of three groups: low dose group (0.3mg/kg), middle dose group (0.4mg/kg), or high dose group (0.5mg/kg). The successful rates of different doses of nifekalant instant cardioversion were reported in terms of count and percentage, respectively.
The occurrence of adverse events, including sinus bradycardia, cardiac arrest, Torsade de points and ventricular fibrillation confirmed in standard 12-lead ECGs and intracardiac electrograms within 30 minutes among different treatment groups.
Time frame: up to 12 months
The occurrence of adverse events, such as sinus bradycardia, cardiac arrest, Torsade de points and ventricular fibrillation confirmed in standard 12-lead ECGs were represented in terms of count and percentage, respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nifekalant in people with Atrial Fibrillation, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the successful rates of different doses of nifekalant instant cardioversion of persistent atrial fibrillation after radiofrequency ablation (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.